China NMPA Launches Pilot Reform for Expedited Review of Innovative Drug Clinical Trials; GSK Reports 13% YoY Revenue Growth in Q2

Aug 01, 2024 17:18 CST Updated 17:18

GSK

Pharmaceutical R&D Manufacturer

Source: 21st Century Economic Report

Editor: Ji Yuanyuan, Xu Qiulian

Welcome to follow the latest events in the pharmaceuticals and health industry with the 21st Century Economic Report's New Health team!

Policy Trends

NMPA Launches Pilot Reform for the Review and Approval of Clinical Trials of Innovative Drugs

On July 31, according to the National Medical Products Administration (NMPA), Li Li, Secretary of the Party Committee and Director of the NMPA, presided over a meeting on July 30 to review and approve the "Pilot Work Plan for Optimizing and Innovating Drug Clinical Trial Evaluation and Approval" (hereinafter referred to as the "Plan"). This pilot program focuses on the key links that limit the speed of clinical trials for innovative drugs, exploring the establishment of work systems and mechanisms to improve the quality and efficiency of drug clinical trials. The goal is to complete the evaluation and approval of clinical trial applications for innovative drugs within 30 working days, promoting the objective of shortening the start time for drug clinical trials in pilot regions. The "Plan" will be released soon.

21 Comments: Since the beginning of this year, many regions in China have also introduced policies to support innovative drugs. However, the focus of local policies varies. With the release of this "Plan," the key bottleneck in clinical trials for innovative drugs is being addressed. The top-level design of the innovation industry chain and local supporting policies are gradually improving, propelling China's biopharmaceuticals sector towards high-quality development.

National Administration of Traditional Chinese Medicine: Complete the formulation of 210 TCM standards by the end of 2026

On July 31, the National Administration of Traditional Chinese Medicine issued the "Action Plan for Standardization of Traditional Chinese Medicine (2024-2026)," stating that by the end of 2026, a structurally reasonable standard system to meet the needs of high-quality development of traditional Chinese medicine will be basically established. The standard system for traditional Chinese medicine will continue to be optimized and improved, with the completion of establishing 180 domestic standards and 30 international standards for traditional Chinese medicine.

Notice on Accelerating the Inclusion of Village Clinics into Medical Insurance Designated Management by the National Healthcare Security Administration and the National Health Commission

On July 31, the National Healthcare Security Administration, in conjunction with the National Health Commission, issued the "Notice on Accelerating the Inclusion of Village Clinics into Medical Insurance Designated Management." The notice emphasizes placing rural healthcare work at an important position in rural revitalization and improving the accessibility of medical treatment and drug purchases for common and frequently occurring diseases. Through various means, it ensures that eligible village clinics are included in medical insurance designated management by the end of 2024. In cases where multiple village clinics exist within a single administrative village, at least one clinic must be covered under medical insurance designated management, ensuring "medical insurance access in every village" to facilitate convenient local access to medical services for residents.

Drug and Device Approval

Suzetrigine Granted FDA Priority Review Status

On July 31, Vertex Pharmaceuticals announced that the U.S. FDA had accepted its New Drug Application (NDA) for the investigational therapy suzetrigine (VX-548). Suzetrigine is an oral, selective NaV1.8 pain signaling inhibitor intended for the treatment of moderate to severe acute pain.

Roche's Bispecific Antibody Vabysmo Receives EU Approval

On July 31, Roche announced that the European Commission (EC) has approved the bispecific antibody Vabysmo (faricimab) for the treatment of vision impairment caused by macular edema due to retinal vein occlusion (RVO). This is the third indication for Vabysmo in the EU, following previous approvals for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). These three retinal conditions collectively affect nearly 80 million people and are one of the leading causes of vision loss worldwide.

New Industry Obtains 2 Medical Device Registration Certificates

On July 31, Shenzhen New Industries Biomedical Engineering Co., Ltd. announced that the company had recently received two Medical Device Registration Certificates issued by the Guangdong Provincial Drug Administration. The specific products include the Anti-β2-Glycoprotein 1 Antibody IgA Assay Kit (Magnetic Particle Chemiluminescence Method) and the Prealbumin Assay Kit (Immunoturbidimetry Method). The validity periods of the registration certificates are from July 24, 2024, to July 23, 2029, and from July 29, 2024, to July 28, 2029, respectively.

Financial Report Disclosure

Pfizer Raises Full-Year Revenue Guidance by $1 Billion

Pfizer Announces Q2 2024 Results: Revenue of $13.283 Billion, Up 2% Year-over-Year

GSK's Q2 Revenue Grows 13% Year-on-Year to £7.884 Billion

On July 31, GSK announced its Q2 revenue for 2024 reached £7.884 billion, a year-over-year increase of 13%; the H1 revenue amounted to £15.247 billion, marking a 12% year-over-year growth, or 13% excluding COVID-19 products. Specifically, all three business segments achieved growth in Q2: Specialty Medicines grew by 22%, followed by General Medicines with 12% growth, while Vaccines increased by only 3%. Additionally, all three regions—U.S., Europe, and International—reported growth. This demonstrates that GSK's business is showing positive development across all dimensions. Based on this, the company has raised its full-year performance outlook from the previous growth range of 5%-7% to 7%-9%.

Huatai Dain's revenue in the first half of the year was approximately 1.154 billion yuan.

On July 31, Huatai Dain released its semi-annual earnings report, stating that in the first half of 2024, its operating revenue was approximately 1.154 billion yuan, an increase of 0.1% year-on-year; the net profit attributable to shareholders of the listed company was about 332 million yuan, an increase of 3.12% year-on-year; basic earnings per share were 1.42 yuan, an increase of 3.65% year-on-year. Among this, the pharmaceuticals sector achieved operating revenue of 1.136 billion yuan and net profit of 631 million yuan, representing year-on-year growth of 0.47% and 0.30%, respectively.

Capital Market

Luoqi Bio officially announces the completion of nearly 300 million yuan in B-round financing

On July 31, Shanghai Luoqi Biomedical Technology Co., Ltd. officially announced: the successful completion of nearly 200 million yuan in B2 round financing. This round of financing was led by Qiming Venture Partners, with participation from Huangpu Biomedical Industry Fund and Jiuyu Investment. Existing shareholder Shengdi Investment continued to increase its investment. The company also announced the successful conclusion of its B-round financing, accumulating nearly 300 million yuan in funding. Previously, Luoqi Biomedicine completed the B1 round of financing in December 2023, led by Shengdi Investment with participation from Guosheng Capital.

Industry Highlights

Shapuaisi's Actual Controller Lin Hongyuan Plans to Transfer 1.58% Shares to Yhe Medical

On July 31, Sapaias issued an announcement stating that the company received the "Notice of Signing the Share Transfer Agreement" from Yihuo Medical, one of the controlling shareholders' acting-in-concert parties, and Lin Hongyuan, one of the actual controllers, today. On July 31, 2024, Lin Hongyuan, one of the actual controllers of the company, signed the "Equity Transfer Agreement" with Yihuo Medical. Lin Hongyuan intends to transfer 6 million shares (accounting for 1.58% of the total share capital) held in the company to Yihuo Medical through a contractual transfer. The total transfer price for this transaction is RMB 38.28 million, with a per-share transfer price of RMB 6.38. The source of funds for Yihuo Medical to acquire the company's shares will be its own funds or self-raised funds.

Estun Plans to Transfer 10% Equity of Estun Medical to Paralyser

On July 31, Estun Automation announced that the company plans to transfer its 10.00% equity in Estun Medical to the company's controlling shareholder, Pareast Group, at a transfer price of RMB 24 million. After the transfer is completed, the company will hold 16.68% of Estun Medical's equity.

Tonghua Dongbao: First Patient Dosed in China Phase III Clinical Trial of Semaglutide Injection

On July 31, Tonghua Dongbao announced that in May this year, the company signed a "Commercial Authorization and MAH Cooperation Agreement" with Beijing Zhitai Biopharmaceutical Technology Co., Ltd. regarding the GLP-1 product semaglutide injection. According to the agreement, the company will obtain exclusive commercial rights for ZT001 semaglutide injection (indication: adult type 2 diabetes, current name: THDB0225 injection) in mainland China, as well as the right to jointly develop overseas markets. The cooperative product has completed Phase I clinical trials in mainland China. Tonghua Dongbao has initiated Phase III clinical trials in China and recently completed the first patient dosing.

21 Comments: As a current hot direction, GLP-1 drugs have already attracted significant attention and investment from biopharmaceutical companies both in China and internationally. The ultimate outcome may shift from an innovation competition to a cost competition. As hypoglycemic and weight-loss drugs, GLP-1 drugs have clear quantitative indicators. Therefore, the market leaders will likely emerge as the few companies with the most competitive advantages in efficacy, cost-effectiveness, and patient compliance.

Public Opinion Early Warning

Guobang Pharmaceutical: Cumulatively Repurchased 6.127 Million Shares

On the evening of July 31, Guobang Pharmaceutical announced that from January 27, 2024, to July 31, 2024, the company had cumulatively repurchased 6,127,000 shares through centralized bidding, accounting for 1.10% of the company's total share capital.

Hutchmed: Net profit attributable to shareholders in the first half of the year was US$25.801 million, a year-on-year decrease of 84.69%.

Hutchmed's latest interim report shows that, for the half-year period ended June 30, 2024, the profit attributable to shareholders was US$25.801 million, a year-on-year decrease of 84.69%; total revenue was US$306 million, a year-on-year decrease of 42.64%.